NOHSP Definitions - I

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

I

Identifiable Information: “Identifiable information” as defined by DHHS regulations means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

Immediate family: An immediate family member includes the associate’s spouse, parent, sibling, child, grandparent, grandchild, as well as the same relatives for the associate’s spouse. (HSP#008)

Informed Consent: The voluntary, educated, decision of an adult individual to participate or to continue to participate in a research study. The informed consent process includes an ongoing discussion about the research study’s purpose, procedures, risks and potential benefits, and the rights of participants. The informed consent form (ICF) is a summary of the information provided to the participant. (HSP#033)

Initial Approval Date: The date of the convened IRB meeting at which the protocol is either approved without stipulations or approved contingent on the investigator’s successful response to stipulations.

When the convened IRB reviews a study and has serious concerns or lacks significant information the IRB will review the study and the investigator’s response at a subsequent convened meeting. The date of the meeting at which the IRB completes its review and approves the study is the approval date.

When the expedited review procedure is used, the approval date is the date that the IRB Chair or IRB member(s) designated by the Chair gives final approval to the protocol. (HSP#006)

Institutional Official: The Nemours Associate designated by policy with the regulatory oversight of Nemours research and human research participant programs, including signatory authority on behalf of Nemours on related documents. (HSP#002)

Institutional Review Board: An IRB is a body established under federal regulations to protect the rights and welfare of human research participants. The IRBs are established under the National Research Act of 1974 and function under the Code of Federal Regulations Title 45 Part 46, Title 21 Parts 50 and 56, and other applicable laws and regulations for the protection of human subjects. (HSP#016)

International Conference on Harmonization (ICH): Provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. The FDA ICH Guidance (E6) Good Clinical Practice (GCP) should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. Although the principles established in the GCP guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects. (HSP#043)

Intervention: “Intervention” as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR 46.102(f)]

Interaction: “Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]

Investigational device: A medical device that is the subject of a clinical study. (HSP#075)

Investigational Device Exemption (IDE): FDA approval for clinical testing of an unapproved medical device in human subjects. An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. (HSP#034)

Investigational drug or biologic: A new drug or biologic that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. An investigational drug/biologic may also be defined by one of the following:

A drug/biologic in any of the clinical stages of evaluation (Phase I, II, III) that has not been released by the FDA for general use or cleared for sale in interstate commerce.
Any commercially available drug/biologic proposed for a new use or in an unapproved population.
Any commercially available drug/biologic to be used in new dosage form or method of administration.
Any commercially available drug/biologic that contains a new component.
A new combination of two or more commercially available drug/biologic.

(HSP-076)

Investigational New Drug Application (IND): An application to the FDA that details the data that provide documentation that it is reasonable to proceed with certain human trials with a drug. Technically, an IND is a request for an exemption from the Federal statute that prohibits an unapproved drug from being shipped in interstate commerce. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. (HSP#034)

Investigator-Sponsor: An investigator who has applied for and holds an IND or IDE. (HSP#067)

IRB approval: The determination of the IRB that the research/clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. (HSP#029)

IRB Authorization Agreement: A legal agreement prescribed by OHRP that describes the obligations of both parties when one relies upon the other for IRB review services. (The OHRP template for this Agreement is found here: http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf. (HSP#002)

IRB Chair: The IRB member who is responsible for conducting meetings of the IRB, delegation of specific IRB responsibilities as permitted by regulation and overseeing the conduct of the duties of any individuals, subcommittees or ad hoc groups with delegated responsibilities. (HSP#009)

IRB Leadership Group: Committee consisting of the NOSHP Director and Program Manager, all IRB Chairs and Co-Chairs, and the IRB Coordinators. (HSP#018)

IRB Roster: A document containing information about each member’s education, gender, ethnicity, affiliation, scientific status and relevant experience that is used to determine membership requirements, assign reviewers and determine quorum. (HSP#009)